TMJ FOSSA-EMINENCE AND CONDYLAR PROSTHESIS SYSTEM
FDA premarket approval P000023/S011 · decided 2015-02-13
Approval details
- PMA number
- P000023
- Supplement
- S011
- Supplement type
- 30-Day Notice
- Trade name
- TMJ FOSSA-EMINENCE AND CONDYLAR PROSTHESIS SYSTEM
- Generic name
- Joint, temporomandibular, implant
- Applicant
- Nexus CMF, LLC
- Date received
- 2015-01-16
- Decision date
- 2015-02-13
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LZD
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Golden, CO
- Statement
- CHANGES IN TWO CLEANING PROCESSES.
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